Previous evidence suggested that pausing the BTKi drug around the time of vaccination may improve the antibody response. However, the trials results showed no significant difference in antibody levels between those who paused their medication and those who continued their treatment as usual.
Reassuring evidence
The trial, involving 11 hospitals across the UK, involved 99 adults with well-controlled CLL who had been on BTKi therapy for over a year. Participants were randomly assigned to either pause their BTKi drug for one week before and two weeks after vaccination or to continue their medication without interruption. The study measured immune responses before vaccination, three weeks after, and twelve weeks post-vaccination.
The research team found that pausing BTKi therapy did not result in higher antibody levels compared to continuing the medication, and that the quality of the antibody response was similar in both groups. No serious side effects were reported, and the immune response remained consistent twelve weeks after vaccination.
As the study found no clear evidence that a pause in BTKi therapy improves the immune response to COVID-19 vaccination for people with CLL, patients should continue taking their BTKi drug as normal when receiving their COVID-19 vaccine. Future research using blood samples from the study will aim to understand more about how people with CLL respond to COVID-19 vaccination and how this response might be improved.
Dr Helen Parry, Associate Professor at the University of Birmingham’s Department of Immunology and Immunotherapy, researcher within the Cancer Inflammation theme at the National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre and Chief Investigator of the IMPROVE trial, said:
“Our study provides reassuring evidence for cancer patients and their healthcare providers. It shows that pausing BTKi therapy around the time of COVID-19 vaccination does not improve antibody responses – so patients can safely continue their treatment without compromising their immune response to the vaccine.”